Is NCT06420245 recruiting in San Francisco, CA?

Yes, NCT06420245 is currently recruiting participants at its San Francisco, CA location. This diabetic foot ulcer clinical trial is actively enrolling qualified participants.

How do I join the diabetic foot ulcer clinical trial in San Francisco?

To join this clinical trial in San Francisco, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this San Francisco clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diabetic Foot Ulcer Clinical Trial in San Francisco, CA

About This Diabetic Foot Ulcer Study in San Francisco

The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The study aims to determine the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves wound healing. During the study, participants will visit their doctor weekly over a 12 week period, which is standard for diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.

Sponsor: Legacy Medical Consultants

Who Can Participate

Inclusion Criteria

Ambulatory patients ≥ 50 and ≤ 85 years of age;

Willing and able to provide informed consent;

Willing and able to comply with study requirements;

Presence of Wagner 1 and superficial Wagner 2 DFU extending at least through the dermis provided the DFU is located in the foot distal to the medial malleolus

If multiple Wagner 1 and superficial Wagner 2 DFUs are present, the largest ulcer meeting DFU eligibility criteria will be selected as the index DFU in the study;

Index ulcer is able to be visualized and accurately measured with eKare Insights;

Non-study ulcers must be \> 2 cm (.79 in.) from the index ulcer;

Index DFU identified ≥ 4 weeks prior to study screening and \< 52 weeks from the date of informed consent;

Index DFU area \> 1.0 cm2 (0.39 in.) and \< 25 cm2 (9.84 in.) at screening and at Wound Management Period Visit #1;

Index DFU offloaded according to SOC for entire run-in period, prior to randomization;

Potential participant is under the care of a clinician for diabetic management and other medical conditions (the site PI may assist/direct the patient in the pre-screening period to obtain a PCP).

Index foot has adequate circulation defined as meeting one (1) of the following within 30 days of screening: A. ABI ≥ 0.7 and ≤ 1.3 AND TBI \> 0.7; B. Dorsum transcutaneous oxygen tension measurement (TcPO2) ≥ 40 mmHg; C. Arterial duplex with biphasic flow in BOTH the DP and PT arteries verified by PI and documented.

Exclusion Criteria

Index foot ulcer documented to be caused by a medical condition other than diabetes;

Potential subject has five (5) or more DFUs and/or VLUs in the target limb;

DFU is secondary to Charcot neuroarthropathy;

Treatment with an antibiotic impregnated primary dressing ≤ 4 weeks prior to study screening;

Index ulcer is potentially or confirmed by biopsy to be cancerous;

Index ulcer site has undergone radiation therapy;

Venous leg ulcers in diabetic patients;

Active infection proximal to or at site of index ulcer;

Index foot ulcer reduced in area by ≥ 20% at the end of the 4-week run-in period;

Presence of active osteomyelitis or bone infection as verified by x-ray /MRI within 30 days of visit #1 of the run-in period;

Raynaud's disease;

Unreconstructible arterial ischemia which may lead to nonhealing;

Treatment with immunosuppressants, including systemic corticosteroids for ≥ 2 weeks within 30 days prior to study screening, or are anticipated during study participation;

Any active cancer undergoing treatment ≤ 30 days prior to wound management visit #1 of the run-in period, or is anticipated during study participation;

Treatment with chemotherapy within 30 days of the first study wound management visit of the run-in period, or is anticipated during study participation;

Diabetics with poor metabolic control, defined as HbA1c ≥ 12.0%, within 30 days of visit #1 of the run-in period;

Participation in an investigational device, biologic, or drug study currently or within 30 days of study wound management visit #1 of the run-in period;

Prior use of any advanced skin substitute product on the index ulcer within 60 days of visit #1 of the run-in period;

Index ulcer was continued to be treated after visit #1 of the run-in period and/or anticipate treatment during study participation with any of the following prohibited therapies:

Biomedical or topical growth factor;

Topical steroids applied to the index ulcer surface;

On medications that are considered immune system modulators that could affect graft incorporation;

Scarlet red dressing;

Dakin's solution;

Mafenide acetate;

Zinc sulfate;

Povidone-iodine solution;

Polymyxin/nystatin;

Chlorhexidine;

Patient is taking a cyclooxygenase-2 inhibitor (COX-2 inhibitor); such as, celecoxib (Celebrex, Consensi, Elyxyb), valdecoxib (Bextra), amlodipine (Consensi);

Patient has serum creatinine \> 2.5 mg/dL within 30 days of study wound management visit #1 of the run-in period;

Autoimmune connective tissue disease;

End stage renal disease (ESRD);

Presence of any condition which would seriously compromise the subject's ability to complete this study;

Known history of poor adherence to medical therapy and/or clinic appointments;

Pregnant, or planning to become pregnant during the study;

Life expectancy \< 1 year.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Francisco?

Yes, this clinical trial (NCT06420245) has an active research site in San Francisco, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diabetic Foot Ulcer Treatment Options in San Francisco, CA

If you're searching for diabetic foot ulcer treatment options in San Francisco, CA, this clinical trial (NCT06420245) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Francisco research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetic foot ulcer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diabetic foot ulcer clinical trials near you to find additional studies recruiting in your area.

Diabetic Foot Ulcer Clinical Trial in San Francisco, CA

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